Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497699
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-06-20
Brief Title:
A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery
Sponsor:
Ocumension Therapeutics Shanghai Co Ltd
Organization:
Ocumension Therapeutics Suzhou Co Ltd
Study Overview
Official Title:
A Real-world Study to Evaluate the Efficacy and Safety of 9 Dexamethasone Intraocular Injection for the Treatment of Inflammation Associated With Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts
Detailed Description:
To evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts in real-world clinical settings medical history and follow-up data from 113 subjects of Dexycu group and 150 subjects of external control group will be prospectively collected in Hainan China Additionally questionnaires will be collected from surgeons on 30 cases to evaluate the difficulty duration and safety of the Dexycu injector
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None